| CTRI Number |
CTRI/2025/06/088793 [Registered on: 13/06/2025] Trial Registered Prospectively |
| Last Modified On: |
12/06/2025 |
| Post Graduate Thesis |
Yes |
| Type of Trial |
Observational |
|
Type of Study
|
Cohort Study |
| Study Design |
Other |
|
Public Title of Study
|
The impact of Regional anaesthesia and General Anesthesia for Below Knee Amputations on the length of stay in hospital after Surgery and other complications over 30 days after Surgery in a tertiary hospital in India. |
|
Scientific Title of Study
|
Impact of Regional and General Anaesthesia for Below knee amputations on duration of post operative hospital stay and associated 30 day post-operative outcomes – A retrospective cohort study in a tertiary hospital in India |
| Trial Acronym |
NIL |
|
Secondary IDs if Any
|
| Secondary ID |
Identifier |
| NIL |
NIL |
|
|
Details of Principal Investigator or overall Trial Coordinator (multi-center study)
|
| Name |
Natta Nehemiah Harshil |
| Designation |
Junior Resident |
| Affiliation |
Christian Medical College Vellore |
| Address |
Department of Anaesthesia,
Christian Medical College Vellore,
Vellore - 632004
Tamil Nadu Department of Anaesthesia,
Christian Medical College Vellore,
Vellore - 632004
Tamil Nadu Vellore TAMIL NADU 632004 India |
| Phone |
08220168658 |
| Fax |
|
| Email |
n.harshil@ymail.com |
|
Details of Contact Person Scientific Query
|
| Name |
Smitha Elizabeth George |
| Designation |
Professor |
| Affiliation |
Christian Medical College Vellore |
| Address |
Department of Anaesthesia,
Christian Medical College Vellore,
Vellore - 632004
Tamil Nadu
Vellore TAMIL NADU 632004 India |
| Phone |
04162282105 |
| Fax |
|
| Email |
smitha.lizgeorge@gmail.com |
|
Details of Contact Person Public Query
|
| Name |
Smitha Elizabeth George |
| Designation |
Professor |
| Affiliation |
Christian Medical College Vellore |
| Address |
Department of Anaesthesia,
Christian Medical College Vellore,
Vellore - 632004
Tamil Nadu
TAMIL NADU 632004 India |
| Phone |
04162282105 |
| Fax |
|
| Email |
smitha.lizgeorge@gmail.com |
|
|
Source of Monetary or Material Support
|
| Christian Medical College Vellore |
|
|
Primary Sponsor
|
| Name |
Department of Anaesthesia |
| Address |
Department of Anaesthesia,
Christian Medical College Vellore,
Vellore - 632004
Tamil Nadu |
| Type of Sponsor |
Private medical college |
|
|
Details of Secondary Sponsor
|
|
|
Countries of Recruitment
|
India |
|
Sites of Study
|
| No of Sites = 1 |
| Name of Principal
Investigator |
Name of Site |
Site Address |
Phone/Fax/Email |
| Dr Natta Nehemiah Harshil |
Christian Medical College Vellore |
Department of General Surgery unit 1,2,3 and 4, Payl Brand building,
Christian Medical College Vellore,
Vellore Vellore TAMIL NADU |
08220168658
n.harshil@ymail.com |
|
|
Details of Ethics Committee
|
| No of Ethics Committees= 1 |
| Name of Committee |
Approval Status |
| Institutional Review Board (IRB) office of research Christian Medical College, Vellore, India |
Approved |
|
|
Regulatory Clearance Status from DCGI
|
|
|
Health Condition / Problems Studied
|
| Health Type |
Condition |
| Patients |
(1) ICD-10 Condition: O||Medical and Surgical, |
|
|
Intervention / Comparator Agent
|
| Type |
Name |
Details |
| Intervention |
Nil |
Nil |
|
|
Inclusion Criteria
|
| Age From |
18.00 Year(s) |
| Age To |
99.00 Year(s) |
| Gender |
Both |
| Details |
All patients undergoing elective and emergency Lower limb amputations pertaining to Below knee amputations. |
|
| ExclusionCriteria |
| Details |
1.Patients already intubated prior to presenting to Operating Theatre
2.Patients undergoing other forms of amputations like Ray amputations.
3.Patients undergoing other surgical interventions along with the above mentioned amputations requiring General anaesthesia
4.Patients undergoing General anaesthesia combined with regional analgesia techniques (Epidural / Peripheral nerve blocks).
|
|
|
Method of Generating Random Sequence
|
Not Applicable |
|
Method of Concealment
|
Not Applicable |
|
Blinding/Masking
|
Not Applicable |
|
Primary Outcome
|
| Outcome |
TimePoints |
| Impact of Anaesthetic technique (GA versus Regional) on post operative length of Hospital admission including ICU stay and other postoperative complications for patients undergoing lower limb below knee amputations |
30 days post operative follow up of patients |
|
|
Secondary Outcome
|
| Outcome |
TimePoints |
| Comparing Regional and General anaesthesia, Impact of sociodemographic and comorbidity variables on 30 day postoperative complications (mortality and morbidity). |
30 days follow up of patients undergoing the procedure |
|
|
Target Sample Size
|
Total Sample Size="199" Sample Size from India="199"
Final Enrollment numbers achieved (Total)= "Applicable only for Completed/Terminated trials"
Final Enrollment numbers achieved (India)="Applicable only for Completed/Terminated trials" |
|
Phase of Trial
|
N/A |
|
Date of First Enrollment (India)
|
23/06/2025 |
| Date of Study Completion (India) |
Applicable only for Completed/Terminated trials |
| Date of First Enrollment (Global) |
Date Missing |
| Date of Study Completion (Global) |
Applicable only for Completed/Terminated trials |
|
Estimated Duration of Trial
|
Years="1" Months="1" Days="1" |
|
Recruitment Status of Trial (Global)
|
Not Applicable |
| Recruitment Status of Trial (India) |
Open to Recruitment |
|
Publication Details
|
N/A |
|
Individual Participant Data (IPD) Sharing Statement
|
Will individual participant data (IPD) be shared publicly (including data dictionaries)?
Response - NO
|
|
Brief Summary
|
Lower limb amputations
are regularly performed as a life saving surgeries in the underlying
circumstances of sepsis, peripheral arterial disease or trauma. Peripheral vascular disease (PVD) and
diabetes mellitus (DM) have been identified as primary risk factors for lower
limb amputations. The reasons for limb loss can be classified into the following
categories: patient-specific issues such as comorbidities, presence of foot
lesions, anatomical factors, and healthcare-related factors like access to
healthcare and medical insurance. Indications for amputation are related to the degree of tissue necrosis
or viability, and it is performable in either a single operation or a staged
manner. In general, soft tissue quality and the ability to obtain bone coverage
will guide the adequacy of the level of amputation. Patients who undergo LEA usually have
comorbidities, including hypertension, heart failure, and end-stage renal
disease and are likely to be in an older age group. Furthermore, these patients
have advanced systemic atherosclerotic disease involving not only the
peripheral limbs but also the coronary, cerebral, and renal circulations. Hence
Anaesthetic management for such patients is chosen carefully. Because of ultrasound
guidance, the usage of regional anaesthesia (RA) has increased since 2005.
Additionally, compared to general anaesthesia (GA), RA has a number of
physiological advantages, including as better stump flow, preservation of the
body’s physiological reaction to stress, and comparable or greater analgesia
following surgery. Compared with GA,
neuraxial anaesthesia, in particular, has been associated with lower 30-day
mortality and decreased morbidity, less blood loss, fewer surgical site infections,
and a decreased rate of admission to critical care services after elective
total hip or knee arthroplasty. The aim of the study is
to compare the impact of Regional Anaesthesia and General Anaesthesia on the
Length of Hospital stay and mortality and morbidity of patients in the 30 day
post-op period in Indian Setting |